Clinical evaluation of time to re-hospitalization and renal function of tolvaptan in congestive heart failure patients with volume overload. Prospective randomized controlled trial.

Not Applicable

Recruiting

• Conditions: congestive heart failure

• Registration Number: JPRN-UMIN000009810
• Lead Sponsor: Saiseikai Noe hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-19
• Study Completion: 2016-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who a history of hypersensitivity to tolvaptan 2) Patients with severe hypotention or cardioganic shock 3) Patients with cardiac assist device 4) Patients with dehydration 5) Patients with systolic blood pressure < 90mmHg 6) Patients with serum Na > 147 mEq/L or serum K > 5.5 mEq/L or T- bilirubin > 3.0 mg/dL 7)Patients considered not eligible for the study by the attending doctor due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of change of serum creatinine

Secondary Outcome Measures

Name	Time	Method
body weight, daily urine volume, dyspnea, congestive findings(leg edema, jugular vein dilatation, pulmonary congestion ), serum sodium, serum potassium, cystitis C, time to re-hospitalization.